ONZ · Mechanical Ventilator
Anesthesiology · 21 CFR 868.5895 · Class 2
Overview
| Product Code | ONZ |
|---|---|
| Device Name | Mechanical Ventilator |
| Regulation | 21 CFR 868.5895 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Classification Rationale
Class II (performance standards).
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K152664 | TAV System | New Aera, Inc. | Dec 2, 2016 | SESE |
| K131562 | BREATHE NIOV VENTILATION SYSTEM | Breathe Technologies | Mar 6, 2014 | SESE |
| K103345 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | Feb 11, 2011 | SESE |
| K102525 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | Breathe Technologies, Inc. | Dec 2, 2010 | SESE |
| K100528 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | Breathe Technologies, Inc. | Apr 23, 2010 | SESE |
| K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | Breathe Technologies, Inc. | Jul 20, 2009 | SESE |
Top Applicants
- Breathe Technologies, Inc. — 4 clearances
- New Aera, Inc. — 1 clearance
- Breathe Technologies — 1 clearance
